![]() ![]() In prespecified exploratory subgroup analyses, the 3-year event-free survival benefit seen with pembrolizumab was independent of PD-L1 expression (Table 1) or achievement of pathologic complete response. “A substantial proportion of this group” developed subsequent distant recurrences not yet reflected as such, he added. These distant recurrences were observed in 13.1% of the chemotherapy arm and 7.7% of the pembrolizumab arm, whereas the rates of local recurrence were 4.4% and 3.6%, respectively. This regimen was followed by adjuvant treatment that included nine cycles of placebo (every 3 weeks n = 390).Įvent-free survival was defined as the time from randomization to the first occurrence of disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer, or death from any cause.Įvent by category “unfortunately” showed that the majority were distant recurrences, noted Dr. Placebo (every 3 weeks) plus paclitaxel (weekly) and carboplatin (weekly or every 3 weeks) for four cycles, followed by placebo plus cyclophosphamide and either doxorubicin or epirubicin (every 3 weeks) prior to surgery. This regimen was followed by adjuvant treatment with nine cycles of pembrolizumab (every 3 weeks n = 784).Ĭhemotherapy plus placebo: Neoadjuvant treatment with Pembrolizumab plus chemotherapy: Neoadjuvant treatment with pembrolizumab (200 mg every 3 weeks) plus paclitaxel (weekly) and carboplatin (weekly or every 3 weeks) for four cycles, followed by pembrolizumab (200 mg every 3 weeks) plus cyclophosphamide and either doxorubicin or epirubicin (every 3 weeks) for four cycles prior to surgery. Patients were randomly assigned 2:1 to receive one of the two following regimens: More than 80% of patients expressed PD-L1 (ie, combined positive score ≥ 10), and about half had lymph node involvement. KEYNOTE-522 enrolled 1,174 patients with stage 2 or 3 early triple-negative breast cancer. 0089), which did not meet the predefined boundary for significance ( P =. At the second interim analysis, event-free survival at 18 months was 91.3% with pembrolizumab plus chemotherapy and 85.3% with chemotherapy alone (HR = 0.63 P =. ![]() ![]() “The data presented here have now met statistical significance, with a hazard ratio (HR = 0.63) that is consistent with the previous analysis,” Dr. Based on confirmatory data from KEYNOTE-522, that indication was converted to full approval.Īs previously reported, neoadjuvant pembrolizumab plus chemotherapy resulted in a significant increase in pathologic complete response rate (ypT0/Tis ypN0): 64.8% vs 51.2%, an absolute 13.6% improvement ( P =. The FDA had granted accelerated approval (in November 2020) to pembrolizumab in combination with chemotherapy for patients with locally recurrent unresectable or metastatic triple-negative tumors expressing PD-L1. Food and Drug Administration (FDA) approved pembrolizumab for the treatment of patients with high-risk early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery. “These results support pembrolizumab plus platinum-containing neoadjuvant chemotherapy, followed by adjuvant pembrolizumab after surgery, as a new standard-of-care treatment regimen for patients with high-risk, early-stage, triple-negative breast cancer.”īased on these results, on July 27, 2021, the U.S. “KEYNOTE-522 met its dual primary endpoints,” said lead investigator Peter Schmid, MD, PhD, of the Centre for Experimental Cancer Medicine, Barts Cancer Institute, London. The 3-year event-free survival rate was 84.5% with pembrolizumab/chemotherapy compared with 76.8% with chemotherapy alone, investigators reported during an ESMO Virtual Plenary presentation. 1 This is the first large, randomized, phase III trial to report a statistically significant and clinically meaningful event-free survival result in this population.Īfter a median follow-up of 39 months, at the fourth interim analysis, the pembrolizumab arm had a 37% reduction in event-free survival events (hazard ratio = 0.63 95% confidence interval = 0.48–0.82 P =. The latest analysis of the pivotal phase III KEYNOTE-522 trial demonstrated significant improvements in clinical outcomes with pembrolizumab plus chemotherapy vs chemotherapy alone as a neoadjuvant/adjuvant treatment of triple-negative breast cancer. ![]()
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